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Senior Analytical Development Scientist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Engineering
  • Date posted: 06/03/2017
  • Job reference: J361538A

Senior Analytical Development Scientist

Role overview:

  • Reporting to the Principal Scientist, the senior analytical development scientist will be the site analytical science expert/ lead. The successful candidate will support site analytical challenges, work on life cycle management teams and support process development activities.
  • Site gate keeper and analytical expert - will be expected to be close to all transfers, developments and clearly identify any challenges with analytical methods upfront, along with ways to improve.
  • A technical specialist in protein analytics, including release testing, more complex and advanced analytical technologies
  • Work with QC colleagues:
    • In the development/ transfer of analytical methods.
    • In the troubleshooting of analytical methods (biophysical, physical characterisation and release methods for biopharmaceuticals).
    • As a point of contact across sites for technical issues associated with analytics.
  • Sit on and work with global analytical life cycle management (ALCM) teams
  • Relationships with site leadership, site QC, QA, internal and global Development Sciences, MSAT, R&D.
  • Has strong understanding of product characteristics and impacts of manufacturing process on CQA's.
  • Will propose improved ways of characterising proteins and physical attributed of drug substance and drug product in support of fill finish process development.
  • Mentor other scientists on more advanced or complex theory & equipment technology.

Desired Skills / Knowledge

  • Demonstrated expertise in Protein Science is a must.
  • Strong understanding of biopharmaceuticals, protein science analytics is a requirement.
  • SME expertise in a given area(s) such as, Analytical Method Development, Analytical Characterisation, Biophysical & Physical Characterisation, Release Analytics, Analytical Technology.
  • Proficient in analytical science, technologies, techniques and framework to enable successful process development, method development & transfer; relates efforts and approaches to best-practices & business asks; capable of working on a new analytical technology platforms.
  • Experience with liquid and solid state analytical characterisation and release testing
  • Analytical Characterisation (not limited to the following):
    • Protein Characterisation tools such as CD, FTIR, Fluorescence Spectroscopy, HPLC; SDS-PAGE, ELISA, DCS and other techniques
    • Solid State Characterisation such as DSC, Karl Fisher;
  • Experienced with regulatory bodies and writing pharmaceutical development sections of a product filing.
  • Has demonstrated understanding and application of relevant Compendial and Pharmacopeial standards to their specification of interest.
  • Can review on-going product data (e.g. Periodic Product Performance, Change Control, Process Control Strategy, QC stability trends, Development studies) and make recommendations to changes/enhancements to existing specifications based on risk assessment techniques
  • Can lead others in the completion of Technology transfer technical deliverables; can act as Sending or Receiving Unit Technical Lead
  • Proficient in the application of Drug Development knowledge to one or more products; can work on new and/or existing products.
  • Provides guidance and mentoring to site teams as appropriate.
  • Can understand results, trends, investigations, can troubleshoot method and equipment issues, working logically and systematically to resolve problem.
  • Can perform complex data trending and analysis.
  • Present ideas in a manner that will gain buy-in from major cross functional stakeholders to facilitate implementation of solutions. Comfortable to present at industry forums and answer questions as they arise. May prepare industry papers as required and appropriate.
  • Can present findings of work professionally & objectively.
  • Has experience of interactions with other scientists within network to share best-practice/lessons learnt
  • Skilled problem solver & Excellent Communication Skills

Qualification

MSc or equivalent
Preferred PhD in related science field

Relevant to protein science and analytics

Experience:

Minimum 7 - 10 years' experience in a relevant pharmaceutical or biopharmaceutical role

Call Roberta at 016455250 or email

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